Étude de REGN5678 (anti-PSMAxCD28) avec le cémiplimab (anti-PD-1) chez des patients atteints d'un cancer de la prostate métastatique résistant à la castration
3 novembre 2026 mis à jour par: Regeneron Pharmaceuticals
Une étude de phase 1/2 sur REGN5678 (anti-PSMAxCD28) avec le cémiplimab (anti-PD-1) chez des patients atteints d'un cancer de la prostate métastatique résistant à la castration
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug[s]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.
This study is looking at several other research questions, including:
- Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
- How REGN5678 alone or in combination with cemiplimab works in the body
- How much REGN5678 and/or cemiplimab are present in the blood
- To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
345
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Clinical Trials Administrator
- Numéro de téléphone: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Lieux d'étude
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Seoul, Corée du Sud, 05505
- Recrutement
- Asan Medical Center
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Seoul, Corée du Sud, 03722
- Recrutement
- Yonsei University - Severance Hospital - Colorectal Cancer Clinic
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Gyeonggi-do
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Suwon, Gyeonggi-do, Corée du Sud, 16247
- Recrutement
- The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
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-
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Arizona
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Gilbert, Arizona, États-Unis, 85234
- Recrutement
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, États-Unis, 85054
- Recrutement
- Mayo Clinic
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Tucson, Arizona, États-Unis, 85724
- Recrutement
- University of Arizona
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California
-
Santa Monica, California, États-Unis, 90404
- Recrutement
- John Wayne Cancer Institute (JWCI)
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Colorado
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Denver, Colorado, États-Unis, 80218
- Recrutement
- Sarah Cannon Research Institute (SCRI)
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Recrutement
- Yale University Hospital
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Florida
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Jacksonville, Florida, États-Unis, 32224
- Recrutement
- Mayo Clinic Jacksonville
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Tampa, Florida, États-Unis, 33612
- Recrutement
- Moffitt Cancer Center - McKinley Drive
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Recrutement
- Henry Ford Health
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Recrutement
- Mayo Clinic
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New York
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New York, New York, États-Unis, 10029
- Recrutement
- Icahn School of Medicine at Mount Sinai
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New York, New York, États-Unis, 10461
- Recrutement
- Montefiore Medical Center
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New York, New York, États-Unis, 10016
- Recrutement
- NYU Langone Health Perlmutter Cancer Center
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New York, New York, États-Unis, 10032
- Recrutement
- Columbia University - The Trustees of Columbia University in the City of New York
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Rochester, New York, États-Unis, 14642
- Recrutement
- University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Recrutement
- James Cancer Hospital and Solove Research Institute
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Oregon
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Portland, Oregon, États-Unis, 97213
- Retiré
- Providence Portland Medical Center
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Portland, Oregon, États-Unis, 97239
- Recrutement
- Oregon Health & Science University (3485 S. Bond)
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Recrutement
- Thomas Jefferson University Hospital
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Recrutement
- Lifespan Cancer Institute
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Texas
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Houston, Texas, États-Unis, 77030
- Recrutement
- MD Anderson Cancer Center
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- Recrutement
- Emily Couric Clinical Cancer Center
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West Virginia
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Morgantown, West Virginia, États-Unis, 26506
- Recrutement
- West Virginia University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Key Inclusion Criteria:
mCRPC cohorts (men):
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Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
-
PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
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Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy [ADT]) including at least:
- one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
- 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol
ccRCC cohorts (men and women):
- Histologically or cytologically confirmed RCC with a clear-cell component.
- Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
- Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) [PD-1]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor
Key Exclusion Criteria:
- Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol
- Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
- Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
- Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
- Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
- Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
- Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
- Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: mCRPC - dose escalation cohort
REGN5678 with or without cemiplimab |
Administered as per the protocol
Autres noms:
Administered as per the protocol
Autres noms:
|
|
Expérimental: mCRPC - dose expansion cohort
REGN5678 with or without cemiplimab |
Administered as per the protocol
Autres noms:
|
|
Expérimental: ccRCC - dose escalation cohort
REGN5678 with or without cemiplimab |
Administered as per the protocol
Autres noms:
Administered as per the protocol
Autres noms:
|
|
Expérimental: ccRCC - dose expansion cohort
REGN5678 with or without cemiplimab |
Administered as per the protocol
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase |
Through study completion, up to 5 years
|
|
Incidence and severity of Adverse Event of Special Interests (AESIs)
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase |
Through study completion, up to 5 years
|
|
Incidence and severity of Serious Adverse Events (SAEs)
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase |
Through study completion, up to 5 years
|
|
Number of participants with Grade ≥3 laboratory abnormalities
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase |
Through study completion, up to 5 years
|
|
Incidence of Dose-Limiting Toxicities (DLTs)
Délai: First dose through day 42 of last participant in each dose level
|
Dose Escalation Phase |
First dose through day 42 of last participant in each dose level
|
|
Concentration of REGN5678 in serum over time
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase |
Through study completion, up to 5 years
|
|
Concentration of REGN5678 in combination with cemiplimab in serum over time
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase |
Through study completion, up to 5 years
|
|
Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase - mCRPC cohort |
Through study completion, up to 5 years
|
|
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase - ccRCC cohort |
Through study completion, up to 5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase - mCRPC cohort |
Through study completion, up to 5 years
|
|
ORR per RECIST 1.1 criteria
Délai: Through study completion, up to 5 years
|
Dose Escalation Phase - ccRCC cohort |
Through study completion, up to 5 years
|
|
Incidence and severity of TEAEs
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase |
Through study completion, up to 5 years
|
|
Incidence and severity of AESIs
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase |
Through study completion, up to 5 years
|
|
Incidence and severity of SAEs
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase |
Through study completion, up to 5 years
|
|
Number of participants with grade ≥3 laboratory abnormalities
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase |
Through study completion, up to 5 years
|
|
Concentration of REGN5678 in serum over time
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase |
Through study completion, up to 5 years
|
|
Concentration of REGN5678 in combination with cemiplimab in serum over time
Délai: Through study completion, up to 5 years
|
Dose Expansion Phase |
Through study completion, up to 5 years
|
|
Percentage of participants with ≥50% decline of PSA
Délai: Through study completion, up to 5 years
|
Dose Escalation and Dose Expansion Phases - mCRPC cohorts |
Through study completion, up to 5 years
|
|
Percentage of participants with ≥90% decline of PSA
Délai: Through study completion, up to 5 years
|
Dose Escalation and Dose Expansion Phases- mCRPC cohorts |
Through study completion, up to 5 years
|
|
Presence or absence of antibodies against REGN5678
Délai: Through study completion, up to 5 years
|
Dose Escalation and Dose Expansion Phases |
Through study completion, up to 5 years
|
|
Presence or absence of antibodies against cemiplimab
Délai: Through study completion, up to 5 years
|
Dose Escalation and Dose Expansion Phases |
Through study completion, up to 5 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Trials Management, Regeneron Pharmaceuticals
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 août 2019
Achèvement primaire (Estimé)
15 novembre 2027
Achèvement de l'étude (Estimé)
15 novembre 2027
Dates d'inscription aux études
Première soumission
30 mai 2019
Première soumission répondant aux critères de contrôle qualité
30 mai 2019
Première publication (Réel)
3 juin 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 novembre 2026
Dernière vérification
1 novembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs urologiques
- Carcinome
- Tumeurs rénales
- Carcinome à cellules rénales
- cémiplimab
Autres numéros d'identification d'étude
- R5678-ONC-1879
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All individual patient data (IPD) that underlie publicly available results will be considered for sharing
Délai de partage IPD
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
Critères d'accès au partage IPD
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .